BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3802836 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08810
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS UNABLE TO ADJUST STIMULATION WITH OR WITHOUT THE ANTENNA ATTACHED. THE PROGRAMMER WOULD NOT INTERROGATE. THE PATIENT ALSO REPORTED A STRONG ELECTRICAL CURRENT. THIS STARTED APPROXIMATELY A MONTH PRIOR. WHEN THE PATIENT WENT TO PICK UP HER BABY, SHE WOULD GET ZAPPED UNCONTROLLABLY ON THE BACK SO SHE HAD TURNED IT OFF. IN ADDITION, WHEN SHE PUT HER ARMS ABOVE HER HEAD TO DO HER HAIR SHE ALSO HAD TO TURN OFF THE DEVICE AS SHE WOULD GET ZAPPED. THE PATIENT STATED, IT WAS NOT REALLY A SHOCKING SENSATION, BUT A STRONG CURRENT. THE PATIENT¿S PHYSICIAN DID NOT KNOW ABOUT THE SHOCKING. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN TO CHECK THE SYSTEM. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280344 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR